Safety and Tolerability, PK, and PD Study of Single and Multiple ALXN2080 Doses in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ALXN2080; Drug: Placebo

• Registration Number: NCT05428696
• Lead Sponsor: Alexion Pharmaceuticals, Inc.

Brief Summary

This study is designed to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of ALXN2080 in healthy adult participants.

Detailed Description

Participants will be assigned to 10 different cohorts (6 SAD cohorts and 4 MAD cohorts), each with 8 participants on active treatment with ALXN2080 and 2 participants on placebo. ALXN2080 will be administered under fasted conditions throughout this study, except for the last SAD Cohort 6 in which ALXN2080 will be given with food to evaluate the effect of food on the single-dose pharmacokinetics of ALXN2080.

Study Timeline

• Study First Submitted: 2022-04-26
• Study First Submitted QC: 2022-06-17
• Study First Posted: 2022-06-23
• Study Start: 2022-09-12
• Primary Completion: 2023-04-24
• Study Completion: 2023-05-26
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Healthy is defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead ECG, and clinical laboratory tests.
• Body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg. BMI max is 32 kg/m2.
• Male or female; female of childbearing potential and male participants agreed to follow protocol specified contraception guidance.

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Exclusion Criteria

• Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders.
• History of hypersensitivity to any ingredient contained in the study intervention.
• Evidence of active infections, history of meningococcal infection, unexplained, or recurrent infection.
• Known or suspected history of drug or alcohol abuse or dependence.
• Current tobacco users or smokers.
• Diseases or conditions or previous procedures known to interfere with the absorption, distribution, metabolism, or excretion of drugs.
• For females: pregnant, breastfeeding, or intending to conceive during the course of the study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SAD - Cohort 1	Placebo	Eight participants will receive a single dose of Dose Amount 1 of ALXN2080, and 2 participants will receive placebo.
SAD - Cohort 2	ALXN2080	Eight participants will receive a single dose of Dose Amount 2 of ALXN2080, and 2 participants will receive placebo.
SAD - Cohort 2	Placebo	Eight participants will receive a single dose of Dose Amount 2 of ALXN2080, and 2 participants will receive placebo.
SAD - Cohort 3	ALXN2080	Eight participants will receive a single dose of Dose Amount 3 of ALXN2080, and 2 participants will receive placebo.
SAD - Cohort 3	Placebo	Eight participants will receive a single dose of Dose Amount 3 of ALXN2080, and 2 participants will receive placebo.
SAD - Cohort 4	ALXN2080	Eight participants will receive a single dose of Dose Amount 4 of ALXN2080, and 2 participants will receive placebo.
SAD - Cohort 4	Placebo	Eight participants will receive a single dose of Dose Amount 4 of ALXN2080, and 2 participants will receive placebo.
SAD - Cohort 5	ALXN2080	Eight participants will receive a single dose of Dose Amount 5 of ALXN2080, and 2 participants will receive placebo.
SAD - Cohort 5	Placebo	Eight participants will receive a single dose of Dose Amount 5 of ALXN2080, and 2 participants will receive placebo.
SAD - Cohort 6	ALXN2080	Eight participants will receive a single dose of Dose Amount 6 of ALXN2080, and 2 participants will receive placebo.
SAD - Cohort 6	Placebo	Eight participants will receive a single dose of Dose Amount 6 of ALXN2080, and 2 participants will receive placebo.
SAD - Cohort 1	ALXN2080	Eight participants will receive a single dose of Dose Amount 1 of ALXN2080, and 2 participants will receive placebo.
MAD - Cohort 2	Placebo	Eight participants will receive multiple doses of Dose Amount B of ALXN2080 at a Dosing Frequency 1, and 2 participants will receive placebo for 14 days.
MAD - Cohort 2	ALXN2080	Eight participants will receive multiple doses of Dose Amount B of ALXN2080 at a Dosing Frequency 1, and 2 participants will receive placebo for 14 days.
MAD - Cohort 3	ALXN2080	Eight participants will receive multiple doses of Dose Amount C of ALXN2080 at a Dosing Frequency 1 or Frequency 2, and 2 participants will receive placebo for 14 days.
MAD - Cohort 1	ALXN2080	Eight participants will receive multiple doses of Dose Amount A of ALXN2080 at a Dosing Frequency 1, and 2 participants will receive placebo for 14 days.
MAD - Cohort 3	Placebo	Eight participants will receive multiple doses of Dose Amount C of ALXN2080 at a Dosing Frequency 1 or Frequency 2, and 2 participants will receive placebo for 14 days.
MAD - Cohort 1	Placebo	Eight participants will receive multiple doses of Dose Amount A of ALXN2080 at a Dosing Frequency 1, and 2 participants will receive placebo for 14 days.
MAD - Cohort 4	ALXN2080	Eight participants will receive multiple doses of Dose Amount D of ALXN2080 at a Dosing Frequency 1 or Frequency 2, and 2 participants will receive placebo for 14 days.
MAD - Cohort 4	Placebo	Eight participants will receive multiple doses of Dose Amount D of ALXN2080 at a Dosing Frequency 1 or Frequency 2, and 2 participants will receive placebo for 14 days.

Primary Outcome Measures

Name	Time	Method
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Day 1 through up to Day 28

Secondary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax) of Single Dose ALXN2080	Up to 168 hours postdose
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC0-inf) Of Single Dose ALXN2080	Up to 168 hours postdose

Trial Locations

Locations (1)

Clinical Trial Site; 🇬🇧 Belfast, United Kingdom